PhRMA Seeks to Eliminate Pharma Antitrust Reporting Requirements
Background.
On February 7, 2014, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group composed of research-focused pharmaceutical and biotechnology companies, filed a motion in the U.S. District Court for the District of Columbia to invalidate the Premerger Notification; Reporting and Waiting Period Requirements Final Rule (Rule) promulgated by the Federal Trade Commission.
As we discussed on December 16, 2013, this new Rule adopts an “all commercially significant rights” test to determine whether a transfer of assets has occurred in an exclusive patent license agreement. The new Rule applies only to the pharmaceutical industry.
PhRMA’s Complaint.
PhRMA filed a Complaint seeking injunctive relief against the FTC, No. 1:13-cv-01974-BAH, (D. D.C. 2013), just days before the final rule took effect on December 16, 2013. The Complaint alleges the following: (1) the new Rule exceeds the FTC’s statutory authority under the Hart Scott Rodino (HSR) Act; (2) … Read More »
Final FDA Guidance Clarifies “Dear Doctor” Letter Requirements
On January 23, 2014, the United States Food and Drug Administration (“FDA”) released a final guidance entitled Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 75 Fed. Reg. 3827 (“Final Guidance”), available here, in which the Agency provides recommendations regarding when to issue a Dear Health Care Provider (“DHCP”) letter, what information to include in a letter, how to organize the information, and how to format letters for ease of access by health care providers.
Emphasizing effective and prompt communication goals, the FDA encourages pharmaceutical and biologics manufacturers to consult with the Agency “to ensure that the letter clearly and accurately reflects both the manufacturer’s and FDA’s understanding of the issues and the action required,” including a determination of the following:
Whether a DHCP letter is needed to convey new or important information;
How to format and present the new … Read More »
FTC Amendments to Premerger Notification Rules: The Who, What & Why
On November 6, 2013, the Federal Trade Commission released final amendments to the Hart-Scott-Rodino Premerger Notification Rules to clarify when a transaction involving the transfer of rights to all or part of a pharmaceutical (including biologics) patent is reportable under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”).
The final rule, which is the same as the proposed rule circulated a year ago for public comment, codifies an “all commercially significant rights” test to determine whether a transfer of rights has occurred in an exclusive patent license agreement. Under that rule, if a patent licensor transfers all commercially significant rights to the patent, the transaction may be reportable. The final rule states that if “limited manufacturing rights” are retained by the licensor, then the transaction may also be reportable under the Act.
The final rule, which takes effect on December 16, 2013, is available … Read More »
“Dear Doctor” Letters: FDA Removes Behavior Tracking Recommendations from Proposed Guidance
On July 9, 2013, the United States Food and Drug Administration (FDA) announced a modification of certain recommendations contained in the November 2010 draft guidance (Guidance) relating to the content, format, and dissemination of Dear Health Care Provider (DHCP) letters communicating important safety information by manufacturers or distributors of medications or biologics. Specifically, the FDA revised a provision recommending that manufacturers evaluate the extent to which their target audience receive the letters and are aware of the communicated information and removed a provision requiring manufacturers to assess the overall impact of the letters on behavior modification.
Regulating the Content of Dear Health Care Provider Letters
The November 2010 Guidance details recommendations relating to the content and format of DHCP letters. See 75 FR 69449 (Nov. 12, 2010). DHCP letters are used to inform health care professionals about important new safety concerns that … Read More »
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »